Interferon ß-1a ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎44

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004505-32-DE
(EUCTR)
06/07/202125/05/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: Glatiramer acetate
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Product Name: Glatiramer acetate
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Product Name: Interferon ß-1b
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Spain;Germany;United Kingdom;Italy
2EUCTR2020-004505-32-FR
(EUCTR)
09/06/202126/04/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Product Name: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Product Name: Interferon ß-1b
Other descriptive name: INTERFERON BETA-1B
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Germany
3EUCTR2011-005677-23-HR
(EUCTR)
25/11/201501/02/2016Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
4EUCTR2011-005677-23-EE
(EUCTR)
21/11/201422/10/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
5EUCTR2011-005677-23-RO
(EUCTR)
08/10/201430/05/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany;Sweden
6NCT02283853
(ClinicalTrials.gov)
August 28, 20143/11/2014Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label ExtensionRelapsing-Remitting Multiple SclerosisDrug: dimethyl fumarate;Drug: Interferon ß-1aBiogenNULLActive, not recruiting10 Years17 YearsAll156Phase 3United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Kuwait;Poland;Serbia;Spain;Sweden;Turkey;United Kingdom;Argentina;Czech Republic;Romania
7EUCTR2011-005677-23-NL
(EUCTR)
19/08/201425/02/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Estonia;Slovakia;Spain;Lithuania;Austria;United Kingdom;Italy;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Netherlands;Latvia;Germany;Sweden
8EUCTR2011-005677-23-SE
(EUCTR)
07/08/201412/03/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
9EUCTR2011-005677-23-GB
(EUCTR)
15/07/201412/03/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
10EUCTR2011-005677-23-AT
(EUCTR)
24/01/201419/12/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Sweden
11EUCTR2011-005677-23-PL
(EUCTR)
13/01/201420/11/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
12EUCTR2013-002082-19-NL
(EUCTR)
09/01/201417/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
13NCT01975298
(ClinicalTrials.gov)
January 201428/10/2013A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).Relapsing Remitting Multiple SclerosisDrug: Laquinimod;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLWithdrawn18 Years55 YearsAll0Phase 3Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
14EUCTR2011-005677-23-DE
(EUCTR)
16/12/201309/04/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Sweden
15EUCTR2013-002082-19-FI
(EUCTR)
04/12/201315/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
16EUCTR2013-002082-19-DK
(EUCTR)
03/12/201303/12/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
17NCT02047734
(ClinicalTrials.gov)
December 3, 201326/1/2014Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study)A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis PatientsRelapsing Multiple SclerosisDrug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placeboCelgeneNULLCompleted18 Years55 YearsAll1320Phase 3United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom
18EUCTR2011-005677-23-BG
(EUCTR)
28/11/201315/11/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
19EUCTR2013-002082-19-BE
(EUCTR)
25/11/201313/09/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
20EUCTR2013-002082-19-SE
(EUCTR)
21/11/201313/09/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
21EUCTR2013-002082-19-GB
(EUCTR)
13/11/201306/11/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden
22NCT01892722
(ClinicalTrials.gov)
July 26, 20138/5/2013Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple SclerosisA 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon ß-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension PhaseMultiple SclerosisDrug: Interferon beta-1a;Drug: Fingolimod;Drug: Placebo capsule;Drug: Placebo i.m. injectionNovartis PharmaceuticalsNULLRecruiting10 Years17 YearsAll220Phase 3United States;Australia;Austria;Belarus;Brazil;Bulgaria;Canada;Croatia;Estonia;France;Germany;Italy;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;South Africa
23EUCTR2011-005677-23-LT
(EUCTR)
10/05/201311/02/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3United States;Serbia;Belarus;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
24EUCTR2011-005677-23-LV
(EUCTR)
29/04/201319/03/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase. Relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
25EUCTR2011-005677-23-ES
(EUCTR)
26/04/201309/04/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Farmaceutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Brazil;Spain;Lithuania;Latvia
26EUCTR2011-005677-23-IT
(EUCTR)
02/04/201311/02/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis FarmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Spain;Brazil;Lithuania;Latvia;Italy
27EUCTR2011-005677-23-SK
(EUCTR)
27/03/201304/03/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase - PARADIGMS Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3Russian Federation;United States;Austria;Latvia;Netherlands;Sweden;Brazil;Poland;Slovakia;Bulgaria;France;Lithuania;Serbia;Croatia;Romania;Ukraine;United Kingdom;Belarus;Spain;Canada;Turkey;Italy;Mexico;South Africa;Australia;Germany;Estonia
28EUCTR2009-012500-11-IT
(EUCTR)
18/06/201021/05/2010Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - NDMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Daclizumab HYP
Other descriptive name: Daclizumab HYP
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1500Slovenia;Greece;Finland;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
29NCT00883337
(ClinicalTrials.gov)
April 200916/4/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension PeriodMultiple SclerosisDrug: Interferon ß-1a;Drug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll324Phase 3Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom
30EUCTR2007-005450-23-DE
(EUCTR)
29/12/200828/10/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA-1A
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy
31EUCTR2007-005450-23-LT
(EUCTR)
27/08/200807/05/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A (Avonex®)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
32EUCTR2007-005450-23-BG
(EUCTR)
29/05/200827/05/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania
33NCT00605215
(ClinicalTrials.gov)
April 24, 20088/1/2008BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded DesignMultiple SclerosisDrug: Laquinimod;Drug: Placebo;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll1331Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey
34EUCTR2007-005450-23-CZ
(EUCTR)
14/04/200812/02/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
35EUCTR2007-005450-23-SK
(EUCTR)
10/04/200830/04/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;Italy
36EUCTR2007-005450-23-EE
(EUCTR)
28/03/200811/02/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Product Name: -
Product Code: -
INN or Proposed INN: interferon beta-1a
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy
37EUCTR2006-000704-17-BE
(EUCTR)
25/04/200706/07/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Greece;Spain;Belgium;Austria;Germany;Italy;United Kingdom
38EUCTR2006-000704-17-HU
(EUCTR)
16/04/200727/07/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
39EUCTR2006-000704-17-GR
(EUCTR)
19/12/200611/08/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Product Name: Interferon beta-1a
INN or Proposed INN: interferon beta-1a
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Phase 3Portugal;Hungary;Greece;Belgium;Spain;Austria;Germany;Italy;United Kingdom
40EUCTR2006-000704-17-PT
(EUCTR)
09/11/200602/08/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Trade Name: Avonex
Product Name: Interferon beta-1a
INN or Proposed INN: interferon beta-1a
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Hungary;Portugal;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
41EUCTR2006-000704-17-GB
(EUCTR)
19/10/200610/05/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Product Name: Interferon beta-1a
INN or Proposed INN: interferon beta-1a
Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
42EUCTR2006-000704-17-AT
(EUCTR)
08/09/200612/07/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
43EUCTR2006-000704-17-DE
(EUCTR)
21/08/200612/06/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;United Kingdom;Germany;Belgium;Spain;Italy;Greece;Austria
44NCT00340834
(ClinicalTrials.gov)
May 200619/6/2006Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseA 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseMultiple SclerosisDrug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Interferon ß-1a 30 µgNovartisNULLCompleted18 Years55 YearsAll1292Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Egypt;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico